Presentation on endoluminal therapies: Homerton University Hospital, May 16 2011

New Horizons in Bariatric Surgery – endoluminal treatments for weight regain after gastric bypass: Elliot R Goodman MD Bariatric Surgery Service Beth Israel Medical Center New York, NY

Background
150,000-200,000 bariatric operations done a year
Weight loss of 67-75% EBWL in 80% of patients in 2 years
14 year follow up study: 95% of patients maintained at least 50% EBWL
Pories WJ, Swanson MS, MacDonald KG. Who would have thought it? An operation proves to be the most effective therapy for adult-onset diabetes mellitus. Ann Surg 1995;222:339-350.

Background
Estimated 10% - 20% will regain some weight at 5 and 10 years
Usually a nadir weight is reached at 2 years
Weight regain
Mean 10-20% weight gain above nadir weight
Many patients dropping below 50% of % EBWL after primary surgery
>25% of RYGB patients regain almost all of their lost weight
Linear relationship between % weight regain and GJ stomal diameter (Dayyeh, Lautz, Thompson, 2011)
12% incidence of revision after gastric bypass surgery for weight regain

Weight loss trajectory after gastric bypass:

Background
Review of Literature on Reoperative Bariatric Surgery
838 patients - open reoperation
118 major complications (14%)
11 deaths (1.3%)
64 patients - laparoscopic reoperation
6 major complications (9%)
Average OR time 4.5 hours
Jones KB. Revisional bariatric Surgery-potentially safe and effective. SOARDS 1 (2005) 599-603

Background:
2008 ASMBS Member Survey
What is the weight loss expectation for an endoluminal revisional procedure
76% felt 10-20% EWL at 12 months with safety equivalent to that of a therapeutic endoscopy was acceptable
Brethauer SA, Pryor AD, Chand B et al Endoluminal procedures for bariatric patients: expectations among bariatric surgeons (2009) Surg Obes Relat Dis Mar-Apr;5 (2): 231-6

Endoluminal Gastric Pouch Reduction (EGPR) StomaphyX TM

Endoluminal Gastric Pouch Reduction
StomaphyX TM (EndoGastric Solutions, Redmond WA)
FDA approved in the United States for endoluminal tissue approximation
CE marked in Europe
Patients who want further weight loss
Patients with rapid gastric emptying or dumping syndrome associated with diarrhea

Procedure
Average 20-40 3-0 polypropylene fasteners per case
Start 1 cm proximal to stoma- 12-16 fasteners
1-2 cm proximal to first row- another 12-16 fasteners
Additional fasteners until 1cm below GE junction reached

Diagram for fasteners H H H H H H

Endoluminal Gastric Pouch Reduction Pre anastomosis Post anastomosis

Endoluminal Gastric Pouch Reduction Gastro-esophageal Junction

Fluoroscopic evidence of stomal narrowing after EGPR with Stomaphyx: GJ stoma before EGPR Stoma after EGPR

Serosa-to-serosa Fusion Full thickness tissue plication and serosa-to-serosa fusion seen in several animal models

Beth Israel Medical Center results 2008-9 (N=64) Age (years) 47.5 (24-66) Female / Male 92% female / 8% male Height (inches) 65 Median BMI Pre-Gastric Bypass 48.7 Median BMI Post-Gastric Bypass (nadir) 31.3 Median BMI Post-GB(nadir) 31.3 Median time(years) after Gastric bypass surgery 5 (2-10)

Median BMI before StomaphyX 39.85 (25.9-54.9) Median BMI post Stomaphyx 37.75(25.1-55.2) Median follow up(months) 6(1-13) No. Patients Weight loss 43(67%) No. Patients no weight loss 14(21%) No follow up weight available 7(12%)

Median weight loss (lbs.) post StomaphyX 15.5(3.3-67) Median OR time 50 (35-130) Median reduction in gastric pouch length 33%(0-67) Median # of fasteners 23(10-40)

RESULTS:
Dumping syndrome improved
GERD improved

3 patients underwent repeat procedure due to unsatisfactory results.
Maximum weight loss: 67 lbs
Postprandial diarrhea/GERD resolved.
Slowed gastric emptying
Obliteration of the gastrocolic reflex
New valve created just distal to GE junction

Latest data pooled from 3 large US centers (BIMC, OSU and Alvarado Hospital):
124 patients underwent EGPR at three centers
94% female mean age 49(+/-10)yrs mean pre-EGPR BMI 39(+/-8)
Mean 126lbs EWL after GB with 59lbs regained 7.1 (+/-3.7) yrs after GB
Followed for 6 months (+/-4 SD) after EGPR

Latest data (con):
EGPR reduced pouch length by 50(+/-24)%
Mean number of plications 22(+/-9)
Mean weight loss 25lbs – 18% EWL or 43% RWL
Weight loss range - 23lbs gain to 183lbs loss

Predictive factors:
Weight loss after EGPR significantly correlated with weight loss after initial GB (p=0.001)
Lower pre-EGPR BMI predicted better weight loss after EGPR (p=0.009)

Mechanism of Weight loss
Reduction in size of pouch
Reduction in size of stoma
Reduce compliance of pouch
Slowed gastric emptying

The ROSE Procedure (by USGI):

R epair O f S urgery E ndolumenal-ROSE Repair of Dilated Gastric Pouch and Stoma Post RYGBP Dilated Stoma Post ROSE Procedure

ROSE with the USGI IOP Dilated pouch and stoma Stoma restoration: Use EOS to create circumferential folds around stoma Create permanent folds in pouch to reduce volume

ROSE Registry | Site, Patient Mix
9 sites collectively enrolled 116 patients
Targeted cross section of users
Bariatric surgeons
Surgical endoscopists
Gastroenterologists
Targeted cross section of sites
Academic centers
Private community practices

ROSE Registry | Design, Demographics INCLUSION CRITERIA: Broadly defined to collect clinical experience across the full spectrum of revision patients
STUDY DESIGN:
Screening EGD to evaluate for pouch and/or stoma dilatation
Procedure performed under general anesthesia
Routine gastroscopy done pre- and post-procedure to document pouch and stoma measurements
PATIENT DEMOGRAPHICS: AGE TIME WEIGHT ≥ 18 Years old and < 65 Years old ≥ 2 years post Roux-en-Y Bypass Achieved ≥ 50% of EWL after initial RYGB surgery 1 3 6 12 Clinical/Nutritional Follow-Up X X X X EGD Follow-Up X X Gender 101 females (87%) / 15 males (13%) Mean Age 46 years Mean BMI pre-ROSE 40

ROSE Registry | Safety Findings Intra-Op No significant intra-op complications
Early in the experience:
3 patients (<3%) with mucosal esophageal tear intra-operatively
All resolved spontaneously within 24 hours
Discharge Sore Throat (41%) Nausea/Vomiting (12%) 85% discharged the same day Long-Term 12 month EGDs (N=66) documented absence of stricture or ulcer

ROSE Registry | Acute Procedural Success PRE-PROCEDURE 2.6 cm POST-PROCEDURE 0.5 cm INTRA-OP STOMA CHANGE Cases Completed 97% (112/116) Mean Final Stomal Diameter 11.5 mm Mean % Stomal Reduction 50% Mean Final Pouch Length 3.3 cm Mean % Pouch Reduction per Case 44% Mean # Total Anchors per Case 5.9 Mean O.R. Time 87 min

Stoma/Pouch Reduction Achieved Cases Completed N=112/116 (97%) Mean Final Stomal Diameter 11.5 mm Mean % Stomal Reduction 50% Mean Final Pouch Length 3.3 cm Mean % Pouch Reduction per Case 44% Mean # Total Anchors per Case 5.9 Mean O.R. Time 87 min

Results-6 Month Weight Loss *based on target BMI 25kg/m 2 6 Month Endpoint (N=96) Mean for Total Registry Max for Individual Subject Weight Loss (kg) 6.5kg 30kg %EWL* 18% 84% % Regained Weight Lost (RWL) 32% 300%

ROSE WEIGHT LOSS WITH STOMA REDUCTION SUBSET 12 MONTHS N=73 (min, max) 12 MONTHS N=22 (30% of N) (final stoma <10mm) MEAN WEIGHT LOSS (LBS) 12.9 LBS 22.4 LBS MEAN % EWL (BMI25) 14 % 24 % MEAN %TBW Loss 5 % 9%

Grouped Variable Analysis 6 month ROSE Data Best Positive Group Predictors for %EWL at 6 months * *using linear regression modeling ¥ p<.05 statistically significant Predictive Grouping P-value ¥ %EWL from original bypass 0.0015 # of total anchors placed 0.0267 Female >50 0.0399 Pre-ROSE procedure pouch length 0.3187

Analysis/Discussion
Success post-bypass predicted ROSE success at 6 months (p=.006)
Top 20% RYGB pts (based on initial weight loss) lost 29% EWL at 6 months with ROSE
ROSE stopped weight regain in 88% (84/96) of patients at 6 months

Durability of Plications at 12 (and 24 Month) Endoscopy 24 month EGD post-ROSE 12 month EGDs post-ROSE
Anchors visible on 92% (61/66 patients) at 12 month
EGDs post ROSE

The IOP System for Revision
ROSE plications have been shown to be durable
ROSE proves to be a safe procedure
No major complications have occurred to date
% EWL after initial bypass surgery and reducing a dilated stoma to under 10mm is a valuable predictor of success with ROSE
Results to date begin to meet endoluminal expectations of ASMBS Technology Committee survey for revision (10-20%EWL)
Safety - Achieved
Durability - Achieved
% EWL @ 12 months – On Target

Apollo Endosurgery Overstitch System:

Overstitch :
General application endoluminal platform
Fits over a therapeutic upper endoscope
Uses 2-0/3-0 prolene or vicryl sutures
144 cases performed in last 8 months – 71 pouch or stomal reductions

Apollo Endosurgery Overstitch pilot study for weight regain ( Thompson et al , 2011):
Aim: To demonstrate technical feasibility, safety and short term efficacy
Prospective interventional case series
22 consecutive RYGB patients with weight regain and a dilated GJ stoma

Patient Characteristics: Average pre-bypass weight 342.2+/-75.4lbs Average nadir weight 206.23+/-57.6lbs Average weight at suturing 260.0+/-68.6lbs

Patient Characteristics:
22 RYGB patients presented with weight regain
Age 48+/-9 yrs Gender 16/22 (73%) female Time from RYGB 6+/-2 years Stoma diameter 25.5+/-4.3mm Pouch length 5.3+/-2.0cm

Technique:
Outlet reduction:
Tissue ablation (APC)
Interrupted stitches at the stomal margin
Pouch reduction:
Interrupted stitches in the pouch to reduce its volume

Results:
Technical success: 100%
Post-stomal diameter 5.6+/-1.9mm
Outlet (n=11) Pouch (n=11) Mean procedure time 28.6+/-21.6 mins 14.8+/-9.1 mins Median sutures 3 [1-7] 2 [1-5]

Results: n=18 patients Average weight loss 22.5+/-13.4lbs Average follow-up time 3 months % weight regain loss 60.4% % excess weight loss 21.5%

Stoma vs. Pouch: Outlet reduction n=10 Outlet/pouch reduction n=8 Average weight loss 15.6lbs 30.9lbs Average follow-up time 94 days 86 days % weight regain loss 63.2% 66.1% % excess weight loss 16.7% 26.3%

Conclusions:
EGPR procedures are safe and can produce almost 50% loss of regained weight after 6-12 months
Long term durability still unknown
Pouch size reduction and stomal narrowing appears to treat dumping and GERD in most patients
Behavioral issues still play a major role in determining success after EGPR

Presentation on endoluminal therapies: Homerton University Hospital, May 16 2011

by Beth Israel Medical Center

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Presentation on endoluminal therapies: Homerton University Hospital, May 16 2011 Presentation Transcript

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